Drug Substance Manufacturing Supervisor

To support this next phase, we are recruiting for a Drug Substance (DS) Supervisor who will play a critical role in managing the production activities for Biologics Manufacturing for the 3rd shift operation. This includes supervising cell culture fermentation, protein purification, and aseptic processing to produce high-quality drug substances.

Responsibilities:

• A working supervisor position is shift lead.
• Participate in all drug substance related manufacturing process. Perform (Where needed) and review the process to ensure compliance with the requirements listed in respective batch record.
• Provides daily supervision on the floor to personnel in the efficient use of equipment and materials to produce quality products under cGMP in accordance with the production plan.
• Provides coaching, counseling, development, discipline and recognition of direct staff, including performing annual performance reviews.
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Global Life Science Hub is excited to collaborate with an innovative biopharmaceutical company leading advancements in cutting-edge drug delivery technologies. Following two recent FDA approvals, they are gearing up for substantial growth. By 2025, they will launch new internal manufacturing facilities that will triple their production capacity, driving a significant operational expansion.

To support this next phase, we are recruiting for a Drug Substance (DS) Supervisor who will play a critical role in managing the production activities for Biologics Manufacturing for the 3rd shift operation. This includes supervising cell culture fermentation, protein purification, and aseptic processing to produce high-quality drug substances.

Responsibilities:

• Lead and supervise daily production activities in compliance with cGMPs, SOPs, and Environmental Health and Safety (EHS) guidelines.
• Oversee E. coli cell culture fermentation,...

Global Life Science Hub is partnered with an innovative biopharmaceutical company specializing in difficult-to-formulate biologics. Recently, the company has achieved 2 FDA approvals and is now transitioning from R&D to a full-scale commercial organization. With a highly robust pipeline of advanced assets and expected approvals lined up until 2030, the company is positioned for significant growth.

To support further expansion, we seek a Downstream Manufacturing Supervisor who will be responsible for leading and growing the team while executing purification on a wide range of mammalian based biologics. The ideal candidate should posses technical expertise with various chromatography methods.

Responsibilities:

• Perform and supervise downstream process at multiple scales in a cGMP environment, column packing, process troubleshooting and data analysis.
• Provides technical direction in the execution and development of the purification...

Global Life Science Hub is partnered with an innovative biopharmaceutical company specializing in difficult-to-formulate biologics. Recently, the company has achieved 2 FDA approvals and is now transitioning from R&D to a full-scale commercial organization. With a highly robust pipeline of advanced assets and expected approvals lined up until 2030, the company is positioned for significant growth.

To support further expansion, we seek a Downstream Manufacturing Supervisor who will be responsible for leading and growing the team while executing purification on a wide range of mammalian based biologics. The ideal candidate should posses technical expertise with various chromatography methods.

Responsibilities:

• Perform and supervise downstream process at multiple scales in a cGMP environment, column packing, process troubleshooting and data analysis.
• Provides technical direction in the execution and development of the purification...